In September, I presented the status of eSubmissions in Australia on behalf of the TGA. Since then, the TGA has been busy ensuring a quick and successful implementation of eCTD and setting the foundation for electronic review across all formats.
From the beginning, the TGA “pilot” was kept open allowing anyone to take part that expressed interest. As a result, the first eCTD applications began arriving in October and the first lifecycle sequences in the early parts of 2015.
The TGA have been conducting their review electronically with NeeS for several years now so the move to eCTD has been relatively easy. The successful integration of LORENZ docuBridge was due in part to the cooperation and resource exchanges possible with Health Canada. Health Canada loaned the TGA their key training and support resource for two months. This enabled them to train their evaluators throughout Australia and set up internal processes based on proven know-how.
The involved participation of applicants allowed the TGA to collect valuable feedback from applicants and eCTD Tool vendors as well as evaluators and administrators. These comments were then used to update the specifications from version 0.90 to 3.0.
The AU Specifications v3.0 brought together the NeeS v2.2 guidance and the eCTD pilot guidance in one structure. It also integrated some very useful and unique concepts aimed at enabling applicants to ensure their applications are complete before submission.
The TGA integrated two matrixes into their validation criteria. The Sequence Matrix ensures that valid sequence descriptions are used together with appropriate sequence types. The Document Matrix ensures that the required documents for a particular sequence type have been provided.
The concept of partial baselines was also introduced. Submitting a complete baseline is a time consuming task. While it has obvious benefits to the evaluator, applicants often opt out of the baseline because of time constraints. The TGA allows partial baselines where the applicant can submit only the related data for a particular regulatory activity in a baseline sequence immediately followed by the sequence with the requested changes.
The TGA also encourages file re-use and asks that applicants only submit data once. Thereafter links should be created to the initial location whether that be data within the same sequence, from an earlier sequence or data provided in other applications. This will make the evaluation more efficient. Information already reviewed in earlier sequences or applications does not need the same level of scrutiny that new data requires.
On 1 July 2015, one year after the release of the pilot specifications, the TGA will begin general acceptance of eCTD and complete one of the fastest eCTD implementations done by an agency to date. With plans for a portal and automated services already taking place, expect the TGA to be on the leading edge as the industry moves forward towards RPS and eCTD v4.0
Written by Kent Briggs, Lead Senior Consultant at LORENZ Life Sciences Group.